Kornimate/medical-research-clean huggingface dataset:
safety of inhaled preprandial human insulin in subjects with diabetes and asthma

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Asthma

Summary: this trial is conducted in europe, asia, oceania and the united states of america (usa). this is a one-year clinical trial to compare the safety of inhaled preprandial human insulin to subcutaneous insulin aspart in subjects with type 1 or 2 diabetes and asthma.

the decision to discontinue the development of aerx® is not due to any safety concerns. an analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes * treatment with insulin and/or oral anti-diabetic drugs * asthma for at least 6 months * positive airway reversibility/bronchoprovocation test or documented positive test in the last 3 years * hba1c less than or equal to 11.0 % * body mass index (bmi) less than or equal to 40.0 kg/m2 exclusion criteria: * current smoking or smoking within the last 6 months * other current acute or chronic pulmonary disease excluding asthma * recurrent severe hypoglycaemia * proliferative retinopathy or maculopathy
the effects of basic body awareness therapy on balance, jumping performance and sports injury anxiety in american football players

Conditions: Sport Injury

Summary: this study aims to investigate the effects of basic body awareness therapy (bbat) on balance, jump performance and sports injury anxiety in american football players. participants were divided into two groups, body awareness therapy treatment group (n=22) and a control group(n=22), by computer-based randomization.

this study aims to investigate the effects of basic body awareness therapy (bbat) on balance, jump performance and sports injury anxiety in american football players. participants were divided into two groups, body awareness therapy treatment group (n=22) and a control group(n=22), by computer-based randomization. before starting the study, all participants were given detailed information about the content of the study and filled out a voluntary consent form. all participants in both groups were evaluated under the same conditions and surveys were conducted. the intervention group was given bbat exercises by a physiotherapist who had received bbta training 2 days a week for 6 weeks. all participants continued their team training during this period. at the end of the 6 weeks, all participants were given the same conditions and the surveys were repeated.

Eligibility criteria:
inclusion criteria: * being a licensed american football player * playing in the university league * continue training for at least 1 year * to be between the ages of 18-25 * volunteering to participate in the study * no disabilities for assessment tests exclusion criteria: * orthopedic injury in the last 6 months * having undergone lower extremity surgery in the last 1 year * loss of vision and hearing * presence of a neurological defect- the athlete (if female) is not pregnant

Keywords: american football basic body awareness therapy,
meaning-based group counselling for bereavement

Conditions: Grief; Bereavement

Summary: given that individuals in bereavement tend to experience substantial psychological distress in the first two years following loss, individuals seeking psychological support will need appropriate services grounded in sound empirical scholarship. there is a lack of studies assessing bereavement groups, despite groups being one of the most common forms by which such services are offered. the prominent and emerging process of meaning-reconstruction in bereavement research is theorized to lead to better psychological adjustment and prevent more prolonged grief reactions. the principal objective of this study is to compare two types of group counseling for individuals in bereavement: a novel meaning-based bereavement counseling group and a conventional bereavement support group.


Eligibility criteria:
inclusion criteria: * individuals presenting for bereavement services that have experienced a death-related loss within 6 weeks to 2 years of the first meeting of the group, and are experiencing an uncomplicated grief response will be invited to participate. * individuals will be assessed for their ability to participate in a group counselling context as well as an uncomplicated grief trajectory. participants must be 18 years of age or older, have sufficient ability to communicate in english, as well as read english. exclusion criteria: * following a clinical/diagnostic interview and administration of the pg-13 (prolonged grief disorder-13, prigerson et al., 2009), individuals experiencing a complicated/prolonged grief trajectory are excluded. * furthermore, individuals whose cognitive condition might make the study burdensome or impossible for them are excluded.

Keywords: bereavement grief mourning loss death meaning group counseling psychotherapy uncomplicated support
immune memory of dtpw-hbv/hib vaccine following primary vaccination, immuno & reacto of a booster dose given in infants

Conditions: Whole Cell Pertussis; Diphtheria; Hepatitis B; Tetanus; Haemophilus Influenzae Type b

Summary: to assess the immune memory following primary vaccination of dtpw-hbv/hib vaccine and to assess immunogenicity and reactogenicity of a booster dose given at 15 - 18 months of age.

* subjects who received dtpw-hbv/hib in the primary vaccination without hbv at birth will be randomised (1:3 ratio) to receive either: plain prp at 10 months of age followed by dtpw-hbv at 15-18 months of age or dtpw-hbv/hib at 15-18 months of age. * subjects who received dtpw-hbv + hib in the primary vaccination without hbv at birth will receive dtpw-hbv + hib as a booster. * subjects who received dtpw-hbv/hib in the primary vaccination with hbv at birth will receive dtpw-hbv/hib vaccine as a booster.

Eligibility criteria:
inclusion criteria: for subjects receiving plain prp followed by dtpw-hbv: male or female infant, 10 to 11 months of age, who previously completed the three-dose primary vaccination course with the dtpw-hbv/hib vaccine. for subjects receiving dtpw-hbv/hib or dtpw-hbv + hib: male or female infant, 15-18 months of age, who previously completed the three-dose primary vaccination course with the dtpw-hbv/hib vaccine. for all subjects: * subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol. * free of obvious health problems as established by medical history and clinical examination exclusion criteria: * use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding administration of the study vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to administration of the study vaccine. * planned administration/administration of a vaccine not foreseen by the study protocol starting 30 days before and ending 30 days after administration of the study vaccine with the exception of oral polio vaccine.
helping parents to decide whether they want to be with their child during anesthesia induction

Conditions: Pre-operative Anxiety

Summary: children are distressed at anesthesia induction and this distress can result in maladaptive recovery outcomes. having parents be present at anesthesia induction (ppia) has been suggested as a potential intervention to decrease children's distress, and this intervention is widely favored by parents. however, to date, ppia has not been found to be effective in reducing children's anxiety. the lack of efficacy may be attributable to the fact that parents have generally not been prepared for ppia. the one study that prepared parents (as part of a larger preoperative preparation program) found that ppia with preparation was superior to ppia as previously studied (without preparation). unfortunately, this program is resource intensive and therefore is not clinically feasible. this study will compare ppia with a clinically feasible preparation program to ppia with standard care (minimal preparation). should our intervention show evidence of efficacy, the investigators will have designed a program that is easily translatable to everyday clinical practice. this will, in turn, reduce children's anxiety, improve postoperative outcomes and increase parental satisfaction.


Eligibility criteria:
inclusion criteria: * ages 2 to 10 * scheduled for elective surgical procedure at iwk health centre * mask induction * asa classification i or ii exclusion criteria: * intravenous induction * diagnosed development delay * asa classification iii or higher * pre-medication with benzodiazepine

Keywords: pediatric anesthesia pre-operative anxiety parental presence children elective surgical procedures mask induction
child care wellness study on nutrition and physical activity

Conditions: Overweight; Obesity

Summary: the study is an evaluation of a nutrition and physical activity intervention in child care centers in nc, ca, and ct.

the broad, long term goal is to develop a reproducible nutrition and physical activity intervention which utilizes child care consultant nutrition specialists to reduce the risk of overweight among children in regulated out-of-home child care. the objectives are: 1. to train child care health consultants (cchcs) to become specialists in nutrition consultation in child care such that they will increase their daily consultation activities on nutrition, physical activity, and childhood overweight, 2. to increase child care staff and parental knowledge of and positive attitudes toward providing healthy foods, appropriate portions of foods, and appropriate levels of physical activity for young children in out-of-home child care centers., 3. to strengthen child care center policies, procedures, practices and behaviors, regarding providing healthy foods, appropriate portions of foods, and appropriate levels of physical activity for young children in out-of-home child care centers, and 4. to improve dietary intake and levels of physical activity, and to prevent increases in overweight and the risk of overweight as determined by body mass indexes among children in out-of-home child care centers.

Eligibility criteria:
inclusion criteria: * in each of the three geographical areas (nc, ca, ct), two pairs of community-based child care centers in urban areas with english-speaking directors, kitchens, and with 50-60 children between the ages of 2 and 5 years, 35% of whom are eligible for subsidy. exclusion criteria: * if the randomly selected child care center has an open case of child abuse or neglect.
advanced sensor based functional assessments in axial spondyloarthritis

Conditions: Axial Spondyloarthritis

Summary: this is an observational study using inertial measurement unit (imu) sensors to measure the effects of biological therapy on spinal mobility and function in axial spondyloarthritis. participants will undergo mri scans before and after therapy in parallel to the sensor tests to establish correlation between changes in inflammatory signs and changes in spinal mobility.

we will study 20 participants with active axial spondyloarthritis (axspa) who are about to start biologic therapy as part of routine care. in brief, we will carry out the following assessments before and after therapy: 1. mri of spine and sacroiliac (si) joints - modified stoke ankylosing spondylitis spine score (msasss) scoring 2. record standard patient recorded outcomes (pros): bath ankylosing spondylitis disease activity index (basdai), bath ankylosing global (basg), bath ankylosing spondylitis metrology index (basmi), bath ankylosing spondylitis functional index (basfi), ankylosing spondylitis disease activity score (asdas), ankylosing spondylitis disease activity score health index (asas-hi), euroquol 3 level health assessment (eq5d-3l), work productivity and activity impairment questionnaire (wpai), short questionnaire to assess health enhancing physical activity (squash), 3. erythrocyte sedimentation rate (esr), c-reactive protein (crp) 4. imu sensor tests in clinic for range of motion (rom) in cervical, thoracic and lumbar spine. 5. imu sensor tests at home for standardised function testing

Eligibility criteria:
inclusion criteria: 1. diagnosis of axial spondyloarthritis fulfilling asas classification criteria. 2. age ≥18 years old and \<80 years. 3. fulfilment of local criteria for biologic therapy for axspa. 4. the subjects should be able to read, write, understand and complete study questionnaires. 5. each subject must sign an informed consent form (icf) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. exclusion criteria: 1. safety contra-indication for biologic drug therapy. 2. severely restricted hip movement (less than 20 degrees rotation in either hip). 3. history of previous clinical (symptomatic) vertebral fracture. 4. history of previous spinal surgery. 5. history of previous hip replacement surgery. 6. major scoliosis deformity (in the opinion of the investigator). 7. safety contra-indication for mri assessment. 8. previous biologic agent within 2 months. 9. pregnant or breast-feeding women.
assist: a surveillance study of illicit substance toxicity

Conditions: Overdose, Drug; Drug Use; Drug Abuse; Drug Toxicity; Drug Effect; Illicit Drug Use; Illicit Drug Overdose; Illicit Drug Intoxication

Summary: there is a drug-related death crisis in scotland. this study aims to collaborate with public health scotland in order to assess the feasibility of introducing a surveillance system to the emergency department to highlight illicit drug-related attendances. this will utilise both clinical data and toxiclogical analysis of anonymised samples. the data will inform of prevalence, trend data and utcome of ed patients attending with acute illict drug toxicity.

the purpose of this research is to establish the introduction of a robust toxicology surveillance system in the emergency department (ed) in order to inform public health interests. the study will explore the feasibility of reporting characteristics and causative agents of patients attending hospital as an emergency due illicit substance use. the term illicit substance used during this study encompasses any substance which is not prescribed to the individual and is a controlled drug as per the misuse of drugs act 1971 and misuse of drugs regulations 2001. the study will look at standard care clinical data from all individuals attending the emergency department due to acute illicit drug toxicity. surplus blood samples will be anonymised and analysed for toxicological profiling. the study will allow identification of emerging drug trends and will be shared contemporaneously with public health scotland and inform the scottish government of current incidences to inform public health measures to tackle the drugs death crisis.

Eligibility criteria:
inclusion criteria: * age \>16 * patient attending qeuh ed directly relating to acute illicit drug use * patients with reported acute illicit drug use toxicity who are unwell before they are seen in the emergency department but appear well in the ed should also be included exclusion criteria: * condition more likely due to cause other than acute illicit drug use * condition due to withdrawal of drugs / alcohol * condition primarily related to alcohol use and no evidence of acute illicit drug use * attendance is due to complication of previous drug use - i.e., bbv / infected injection site (without acute drug toxicity)
standardising care for hepatitis delta in the netherlands

Conditions: Hepatitis D

Summary: rationale: hepatitis delta virus (hdv) is a defective rna virus that requires presence of hepatitis b virus (hbv) to complete virion assembly and secretion. hbv-hdv coinfection ("hepatitis delta") has been associated with severe liver injury that may result in rapid progression to cirrhosis and hepatic decompensation, as well as a higher risk of liver cancer when compared to patients with hbv mono-infection. given the low incidence of hepatitis d, experience in caring for individuals with hepatitis delta is limited and management practices vary. objective: generate prospective follow-up data to increase our understanding of this rare disease. study design: prospective observational cohort study spanning 5 years, during which we will collect standard clinical data as well as blood samples and quality of life questionnaires. study population: hepatitis delta patients aged ≥18 years intervention (if applicable): not applicable main study parameters/endpoints: incidence of liver related events (liver cancer, (decompensation of) cirrhosis, liver transplantation) during follow-up and changes in markers of viral replication, inflammatory activity and liver stiffness over time. nature and extent of the burden and risks associated with participation, benefit and group relatedness: the risks associated with participation can be considered negligible and the burden can be considered minimal. the only additional action that the participants must perform are the filling out of two annual quality of life questionnaires, which are considered non-invasive, and collection of 10 ml blood during regular blood sample collections


Eligibility criteria:
inclusion criteria: * active hepatitis delta based on a positive anti-hdv and a positive hdv-rna test * patients must be ≥18 years * written informed consent exclusion criteria: * none
sonographic detection of prophylactic pancreatic stents

Conditions: Pancreatitis; Stent Dislodgement

Summary: the retention of pancreatic stents for prophylaxis of post-ercp pancreatitis (pep) is assessed by abdominal x-ray according to international guidelines. the current study aimed to analyze whether prophylactic pancreatic stents can be detected by transdermal ultrasound to save the x-ray examination.

pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ercp). several pharmacologic and procedure-related measurements have been established for post-ercp pancreatitis (pep) prophylaxis one being the placement of pancreatic duct stents in patients with high risk for pep. the beneficial role of pancreatic stenting in the prophylaxis of pep was demonstrated in large meta-analyses. the used stents have a high potential of self dislodgment, retained stents have to be removed endoscopically after 5-10 days. for evaluation of spontaneous stent passage abdominal x-ray ist used and accordingly retained stents removed. the current study aimed to analyze whether prophylactic pancreatic stents can be detected by transdermal ultrasound to save the x-ray examination.

Eligibility criteria:
inclusion criteria: * patient after pancreatic stent placement for prophylaxis of post-ercp pancreatitis * age 18-79 * signed informed consent exclusion criteria: * any disease that rules out study participation * patient not legally competent to sign informed consent * chronic pancreatis as indication for pancreatic stenting
adolescent mental health inscied out

Conditions: Mental Disorders; Substance-Related Disorders; Social Stigma; Mental Health Wellness 1; Mental Health Impairment

Summary: the study herein seeks to determine whether students undergoing inscied out curriculum in mental health and addiction (called my mind, my body) experience changes in their mental health-related knowledge, attitudes, and help-seeking behavioral intentions. the research group hypothesizes that students undergoing inscied out mental health and addiction curriculum will exhibit pre-post increases in mental health literacy, decreases in mental health stigmatization, and increases in mental health help-seeking behavioral intentions.

integrated science education outreach (inscied out) is one novel program that seeks to promote scientific and health literacy through fostering scientific inquiry. the guiding premise of inscied out's health promotion arm is a concept called prescription education (pe), which uses science education as a direct and early intervention for disease behaviors. the underlying hypothesis of inscied out pe is that a student who lives a scientific experience in his or her own voice (undergoes true inquiry-based science) will be empowered to elect healthier behaviors in any targeted health paradigm. pe's proposed mechanism of change is that inquiry-based science catalyzes transitions from knowledge to understanding to attitudes to intents to actual behavioral change. inscied out partnership with the the school in this study began in spring of 2013 with a projected health promotion arm targeting mental health and addiction. the current iteration of the partnership commenced in summer of 2014 under the annual inscied out summer internship. this internship led to creation of grades 7 and 8 curriculum in mental health and addiction. version 1 of this curriculum was piloted last year. a revised version of the curriculum will be implemented in spring of 2016. although there are education-specific metrics for assessment already built into program evaluation of inscied out, there are currently no clinically relevant inventories in place to specifically probe efficacy of the lesson plans upon key mental health outcomes. the study herein is the establishment of clinically relevant inventories around implemented inscied out curriculum in mental health and addiction (called my mind, my body). these inventories are selected to measure student changes in their mental health-related knowledge, attitudes, and help-seeking behavioral intentions. the research group hypothesizes that students undergoing inscied out mental health and addiction curriculum will exhibit pre-post increases in mental health literacy, decreases in mental health stigmatization, and increases in mental health help-seeking behavioral intentions.

Eligibility criteria:
inclusion criteria: partner school students who do not opt out of and assent to the study exclusion criteria: partner school students opting out of or not assenting to the study

Keywords: science education health promotion mental health promotion stigmatization behavioral intervention